510(k) Report

Devices descending from K955848

95 later devices reach Orthofix Modulsystem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241357XT3 SystemBiodynamik, Inc.20251—
+1K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+1K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.20190—
+1K141760Orthofix Galaxy WristOrthofix Srl201401
+1K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+1K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+1K113770Orthofix Galaxy Fixation SystemOrthofix Srl2012613
+1K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+1K071395Biomet Vision Footring SystemBiomet Manufacturing Corp20071—
+1K052196Vilex X-FixVilex, Inc.200513—
+1K051017R-X-Fix External FixatorR-X-Fix20051—
+1K023714Reprocessed External Fixation DeviceAlliance Medical Corp.20031—
+1K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.2001351
+2K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+2K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.20240—
+2K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd.20210—
+2K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+2K193368Smart Correction SystemWishbone Medical, Inc.202031
+2K202143Dynex MicroVilex, LLC20201—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+2K163653NOVOS-NAIL Limb Lengthening System (LLS)Smith & Nephew20170—
+2K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+2K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+2K150640RX-FIX Mini Rail External FixatorWrightmedicaltechnologyinc20150—
+2K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+2K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+2K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2011292
+2K093753Mdpo Frame SystemMdpo, LLC20100—
+2K100857Fusion Medical Ring Lock SystemJohn J Riccio20101—
+2K052065Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp.20050—
+2K031875Inter-OS Limb LengthenerInter-Os Technologies20034—
+2K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.2003301
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+3K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+3K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+3K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+3K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+3K212552Correx SoftwareVilex, LLC20210—
+3K200343FusionFrame Ring Lock SystemGlw Medical Innovation20200—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K173883External Fixation SystemLife Spine, Inc.20180—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172—
+3K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+3K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201414—
+3K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201321—
+3K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201215—
+3K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+3K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+4K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+4K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K203399Fitbone (R) TaaWittenstein Intens GmbH20219—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+4K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K170146Galaxy UNYCO SystemOrthofix Srl20170—
+4K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+4K163368Fitbone TaaWittenstein Intens GmbH201710—
+4K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated201562
+4K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20153—
+4K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+4K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20149—
+4K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201319—
+5K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K242861TrueLok ElevateOrthofix Srl20243—
+5K233867Fitbone TrochantericOrthofix Srl202421
+5K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+5K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+5K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+5K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20165—
+5K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+5K141739Residual Limb Lengthening SystemEllipse Technologies, Inc.201402
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+6K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+6K250112FitboneTM TrochantericOrthofix Srl20250—
+6K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+6K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+6K170346PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20171—
+6K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—